MTX Hold During Covid-19 Booster

NCT05313061 | Unknown Phase 3 DMC

• 1 other identifier: H-2112-019-1279
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Covid-19 antibody titer before and after Covid-19 vacciation

  Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination

  2 weeks

Secondary Outcomes (2)

• T cell activation after vaccination

  2, 4, 16 weeks

• B cell activation after vaccination

  2, 4, 16 weeks

Study Arms (2)

MTX continue

ACTIVE COMPARATOR

Group will continue MTX after vaccination

Drug: MTX

MTX 1 week hold

EXPERIMENTAL

Group will continue MTX for 1 week after vaccination

Drug: MTX

Interventions

MTX DRUG

MTX continuation

MTX 1 week hold; MTX continue

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 19 years of age at time of consent
• Have a diagnosis of RA per ACR criteria
• Require methotrexate for RA treatment
• Subject to a Covid-19 booster vaccination
• Must understand and voluntarily sign an informed consent form including writing consent for data protection

You may not qualify if:

• Pregnant or lactating females
• Previous anaphylactic response to the vaccine components
• Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
• Any condition including laboratory abnormality which places the subject at unacceptable risk
• Subjects who decline to participate

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

• Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.

  PMID: 29572291 BACKGROUND

• Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.

  PMID: 28468794 BACKGROUND

• Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4.

  PMID: 34346564 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: April 6, 2022
• Study Start: December 29, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)